FDA Approves Cuvitru for Treatment of Primary Immunodeficiencies

U.S. launch expected soon

The FDA has approved the use of Cuvitru (immune globulin subcutaneous [human], 20% solution, Shire) in adult and pediatric patients 2 years of age and older. Cuvitru treats primary immunodeficiencies, a group of more than 300 genetic disorders in which part of the body’s immune system is missing or functions improperly. The disorder affects up to six million people worldwide.

According to Shire, Cuvitru is the only 20% subcutaneous immunoglobulin (IG) treatment option without proline and with the ability to infuse up to 60 mL (12 g) per site and 60 mL per hour per site, as tolerated, resulting in fewer infusion sites and shorter infusion durations compared with other conventional subcutaneous IG treatments. Regardless of the infusion rate or volume per site, Cuvitru was generally associated with a low incidence of local adverse and systemic reactions (0.022 per infusion and 0.042 per infusion, respectively) in a North American study, which was published in the Journal of Clinical Immunology.

Shire expects to launch Cuvitru in the U.S. in the coming weeks.

Source: Shire; September 14, 2016.